Dual-target iTBS for Youth With ADHD

  • STATUS
    Recruiting
  • End date
    Dec 30, 2026
  • participants needed
    15
  • sponsor
    Shanghai Mental Health Center
Send
Updated on 24 July 2025
See if I qualify

Summary

This study will employ accelerated intermittent theta burst stimulation (aiTBS) targeting two transcranial magnetic stimulation (TMS) sites: the right inferior frontal gyrus and left inferior parietal lobule.

Description

ADHD is the most common neurodevelopmental disorder in childhood. First-line clinical treatments primarily rely on psychostimulants, yet approximately 30% of adolescents with ADHD show inadequate response to current therapies. There is an urgent need to develop novel, practical, and sensitive intervention strategies.

Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive technique that modulates neural activity via magnetic fields applied to brain regions beneath the skull, can induce long-lasting positive changes in neuroplasticity. This provides an alternative therapeutic approach for ADHD. In clinical research, rTMS has demonstrated potential value in treating children with ADHD. Notably, current studies have limitations: lack of control groups makes it difficult to exclude placebo effects, and the commonly used DLPFC target shows suboptimal efficacy in improving both clinical symptoms and cognitive functions, indicating room for improvement.

This study will be conducted in two phases:

  • Phase 1 is an open-label, single-arm study to explore the preliminary efficacy, safety, and acceptability of aiTBS for youth with ADHD.
  • Phase 2 is a randomized, double-masked, controlled trial that will rigorously validate the efficacy and safety of dual-target aiTBS and establish causal conclusions through a controlled design.

The decision to proceed depends on Phase 1 results:

  • If Phase 1 demonstrates positive outcomes in clinical symptoms, cognitive functioning, safety, and acceptability, Phase 2 will be implemented.
  • If Phase 1 fails to show positive results, Phase 2 will be discontinued.

The study will utilize MRI-guided neuronavigation to precisely locate the target brain regions (the right inferior frontal gyrus and the left inferior parietal lobule) for each participant. An aiTBS protocol will be employed. Based on a 90% resting motor threshold (adjusted for cortical depth), each participant will receive 10 iTBS sessions (1,800 pulses per session, with 60-minute inter-session intervals), administered twice daily over five consecutive days.

Details
Condition ADHD
Age 10years - 18years
Clinical Study IdentifierNCT07084649
SponsorShanghai Mental Health Center
Last Modified on24 July 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

ADHD Diagnosis: Meets the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Inadequate Response to Medication: After a full course of pharmacological treatment, the SNAP-IV Parent Rating Scale (first 18 items, assessing inattention/hyperactivity-impulsivity) score >1, and the Clinical Global Impression-Severity Scale (CGI-S) score >2
Age and Gender: 10-18 years old; males or females
Intellectual Functioning: Full-scale intelligence quotient (IQ) >70 on the China-Wechsler Intelligence Scale for Children (C-WISC) (excluding participants with intellectual disability)
Symptom Severity: A score of ≥1.6 on either the Inattention or Hyperactivity/Impulsivity subscale of the SNAP-IV Parent Rating Scale
Medication Requirements
) Medication-naïve or currently off medication; 2) If currently on
medication, must be on a stable medication regimen for at least 4 weeks prior
to the baseline visit and throughout the study duration; 3) Prohibited
medications: Psychostimulants; 7. Right-handed

Exclusion Criteria

Contraindications for TMS therapy include epilepsy, cardiac pacemakers, cochlear implants, and metal implants
Contraindications for MRI include metal implants in the body, claustrophobia, and tattoos
Significant medical history: history of epilepsy, organic brain disorders, traumatic brain injury (TBI), or severe physical illnesses
Behavioral risks: history of violent or suicidal behavior
Comorbid neurodevelopmental disorders, such as autism spectrum disorder (ASD), tic disorders, etc
Comorbid psychiatric disorders: any other primary psychiatric disorders, except conduct disorder/oppositional defiant disorder, mild anxiety, or depression
Substance abuse
Currently receiving any non-medical treatments, such as cognitive behavioral therapy (CBT), neurofeedback, etc
Female participants must not be pregnant or breastfeeding
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.